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    Summary
    EudraCT Number:2007-000986-40
    Sponsor's Protocol Code Number:EVT 101/1002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-000986-40
    A.3Full title of the trial
    A double blind, placebo controlled study to investigate the role of NMDA receptor NR2B subunit selective antagonism on cognitive functions and neurophysiology in healthy subjects as measured with MRI
    A.3.2Name or abbreviated title of the trial where available
    The effects of a novel NMDA NR2B-subtype selective antagonist, EVT 101, on brain function
    A.4.1Sponsor's protocol code numberEVT 101/1002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEvotec NeurosciencesGmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code EVT 101
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEVT 101
    D.3.9.3Other descriptive nameENS 10,001; RO 4394127-001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code EVT 101
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEVT 101
    D.3.9.3Other descriptive nameENS 10,001; RO 4394127-001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Investigation of cognitive function and neurophysiology.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    · To investigate neurophysiological changes following EVT 101 with fMRI during rest and cognitive tasks in young healthy male subjects.
    · To investigate the neuropsychological changes following EVT 101 using a validated battery of cognitive tasks, in young healthy male subjects.
    · To relate the effects of EVT 101 on fMRI signal to the effects on performance in cognitive tasks.
    E.2.2Secondary objectives of the trial
    · To determine plasma concentrations of EVT 101 in the subjects (pre-dose, 1, 1.5, 2, and 4h after dosing).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects will be males of any ethnic origin between 18 and 55 years of age and with a body mass index (BMI) between 19 and 29 kg/m2 inclusive.
    2. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable).
    3. Subjects must be right-handed.
    4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
    E.4Principal exclusion criteria
    1. Female subjects.
    2. Subjects who have received any prescribed systemic or topical medication within 5 half-lives or 14 days of the first dose administration, whichever is greater.
    3. Subjects who have received any prescribed CNS medication within 30 days.
    4. Subjects who have used any non-prescribed systemic or topical medication within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
    5. Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration.
    6. Subjects who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 4 months, or a marketed drug within the past 3 months.
    7. Subjects who have donated blood, plasma or platelets in the past month, or who have made donations on more than two occasions within the 12 months preceding the first dose administration.
    8. Subjects with a history of drug allergy to NMDA antagonists or otherwise with a history of clinically significant drug allergy.
    9. Subjects who have any clinically significant allergic disease (excluding non-active hay fever).
    10. Young subjects who have a supine blood pressure and supine heart rate at screening higher than 140/90 mmHg and 90 beats per minute (bpm), respectively, or lower than 80/40 mmHg and 40 bpm, respectively.
    11. Subjects who consume more than 21 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
    12. Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day (including snuff, nicotine patch, nicotine chewing gum, inhaler) and are not able to refrain from using the nicotine containing products during each of the three study periods.
    13. Subjects with intake of caffeine >5 drinks per day on average.
    14. Subjects who are vegetarians.
    15. Subjects with an abnormal acoustic function.
    16. Subjects with, or with a history of, any clinically significant respiratory, metabolic, endocrine, haematological or other major disorders.
    17. Subjects with cardiac pacemakers or other electronic device or ferromagnetic metal foreign bodies (e.g. tattoo).
    18. Subjects with ECG parameters outside of normal ranges as follows: PR <120 msec and >200 msec, QRS>120 msec, QTc >430 msec, HR <40 bpm and >100 bpm.
    19. Subjects diagnosed with disorders such as but not limited to: claustrophobia in enclosed environment, depression, anxiety, panic attack, phobias, schizophrenia, drug overdose or self-harm.
    20. Subjects with a history of psychosis in a first-degree relative.
    21. Subjects who cannot complete the neuropsychological test battery despite having undergone training sessions.
    22. Subjects with abnormal anatomical MRI as defined by radiologist (e.g. tumours, evidence of stroke, localised with matter lesions, excessive atrophy, aneurisms, vascular malformations).
    23. Subjects with, or with a history of, gastritis, peptic ulcer or similar.
    24. Subjects who have any clinically significant cardiac abnormality following review of the 24 hour Holter monitoring by an external cardiologist under the care of RPL.
    25. Subjects who have had a clinically significant illness within 4 weeks of the start of the study.
    26. Subjects who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, have a positive result to the test for HIV antibodies.
    27. Subjects who, in the opinion of their general practitioner (GP) or the Investigator, should not participate in the study.
    28. Subjects who are, in the opinion of the investigator unlikely to comply with the clinical protocol or are unsuitable for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    · change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
    · change in regional Cerebral Blood Flow (rCBF, determined with ASL-MRI), after drug compared with placebo
    · performance scores in the cognitive tests
    · safety/tolerability: adverse events (AE), safety laboratory blood tests, ECG, vital signs
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-18
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